Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health

The UCSD Human Milk Biorepository

The purpose of the UCSD Human Milk Biorepository is to establish and maintain a repository of breast milk samples that can be used to learn more about how breast milk influences infant and child health.

Study Overview

• Status: Recruiting
• Conditions: COVID-19 Vaccine; Breastfeeding; COVID-19 Infection; Antibiotics; Remdesivir
• Intervention / Treatment: Biological: COVID-19 Exposure; Drug: Antibiotic

Detailed Description

Participants in this study will participate in the following:

1. Provide a milk sample:

   If participants agree, the investigators will ask participants to express 50ml (about 2 ounces) of milk. The investigators will take as much as participants wish to donate, or as little as one teaspoon.

2. Answer questions about participant's health:

   Future researchers may need to know if participants have any health problems, or about any treatments participants have had while breastfeeding. The investigators will ask participants for some contact information, health habits, and family's health history.

3. Fill out online questionnaires about participant's eating habits and mood:

   The investigators will ask the participant to answer an online questionnaire about how often participants eat certain foods.

   The investigators will also have the participant answer some questions about the participant's mood and how the participant has been feeling recently. The questionnaires can be completed on a tablet at the visit, or the investigators may send an email with a link to fill it out online. These questionnaires take about 30 minutes altogether.

4. The investigators will store the participant's sample and information in the Human Milk Biorepository:

   The investigators will keep the participant's milk and health information in the Human Milk Biorepository. There is no limit on the length of time we will keep the milk and information. The investigators will keep them as long as they are useful, unless the participant asks to remove them.

5. The investigators will let researchers use the stored materials for approved research studies:

   Researchers can apply to study the samples and information stored in the Human Milk Biorepository.

6. If the participant agrees, the investigators may contact the participant with information about other research studies.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Christina Chambers, PhD, MPH; Phone Number: 858-246-1793; Email: chchambers@ucsd.edu
• Study Contact Backup: Name: Kerri Bertrand; Phone Number: 858-246-1713; Email: kdutcher@ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • Recruiting
      • University of California, San Diego
      • Contact: Christina Chambers, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Any woman who is 18 or older, interested in participating, and is producing sufficient breast milk to donate an excess to the Biorepository will be invited to participate. We may enroll breastfeeding women who are pregnant or women who are pregnant and intend to breastfeed upon birth. We will not exclude any breastfeeding woman based on age (as long as above the legal age of consent), medical condition, or any other factor.

Women will not be excluded based on exposures or lack thereof. We are currently enrolling women who have been or are exposed to:

• Prescription Medications

  • SSRIs
  • Monoclonal Antibody Medications (mABS)
  • All other Rx medications
• Women residing in Southern CA with a baby <6 months of age
• Marijuana

Description

Inclusion Criteria:

• Women who are 18 years old or older
• Breastfeeding
• Producing sufficient breast milk to donate an excess to the Biorepository

Exclusion Criteria:

• Women under 18 years old

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main Study; The purpose of this project is to collect and store breast milk samples and health information about moms and their babies in a Human Milk Biorepository at UCSD. Through these studies, researchers hope to understand more about the benefits of breast milk, and how it prevents or treats child health problems.
Sub-study 100: COVID-19 Exposure; The purpose of this substudy is to learn how exposures to COVID-19 and breastfeeding may affect the development of the child. Women who contact the UCSD Human Milk Biorepository will be screened for possible COVID-19 infection or exposure. Women will be eligible to enroll in the COVID-19 sub-study if they are confirmed positive, are presumptive positive, are symptomatic but not tested, or have confirmed exposure but are asymptomatic.	Biological: COVID-19 Exposure; Have been or may have been exposed to COVID-19.
Sub-study 101: Antibiotic Exposure; The purpose of this substudy is to learn more about maternal use of antibiotics in women who do or do not breastfeed, and how this may influence infant and child health. Women who contact or are referred to the UCSD Human Milk Biorepository will be screened to participate in the Antibiotic Exposure sub-study. Women will be eligible to enroll in the Antibiotic Exposure sub-study if they are 18 years of age or older, have a singleton infant who is <3 months of age at the time of recruitment, and agree to all requirements of the study.	Drug: Antibiotic; Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.
Sub-study 102: P50 MPRINT Admin Supplement; The purpose of this substudy is to review maternal medical exposure and how that may impact various components of human milk, the bacteria in the breastfed infant's gut, and the overall health and development of the breastfeeding child.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Milk Repository	Establish a human milk repository at UCSD	1 year
Develop, maintain and manage the Repository	Develop, maintain and manage the Repository as a resource for investigators to conduct research on the health characteristics and benefits of human breast milk.	Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sub-study 100: COVID-19 Exposure	Develop, maintain and manage collection of other specimens for evidence of exposure to SARS-CoV-2, the virus responsible for COVID-19 disease.	Through study completion, an average of 2 years
Sub-study 101: Antibiotic Exposure	Determine the pharmacokinetics of commonly used antibiotics (e.g., azithromycin, amoxicillin and clavulanic acid, amoxicillin or nitrofurantoin) in human milk samples.	Through study completion, an average of 2 years
Sub-study 102: P50 MPRINT Admin Supplement	Expand enrollment in the UC San Diego human milk research biorepository to include 300 new participants who will provide milk samples paired with maternal and infant blood, stool, skin swabs, and maternal saliva.	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Christina Chambers, PhD, MPH, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2014
• Primary Completion (Estimated): March 1, 2040
• Study Completion (Estimated): March 1, 2040

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Antibiotics; Breastfeeding; Remdesivir; COVID-19 Vaccine; COVID-19 Infection
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 130658

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No